General conditions applied to facilities trading herbal ingredients in Vietnam

This is a content of the Circular No. 03/2016/TT-BYT on herbal ingredient trading issued by the Ministry of Health of Vietnam on January 21, 2016.

Điều kiện chung đối với cơ sở kinh doanh dược liệu, Thông tư 03/2016/TT-BYT

According to Article 4 of the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, general conditions applied to facilities exporting, importing, wholesaling, retailing herbal ingredients, or providing herbal ingredient preservation services are as follows:

- Every facility exporting, importing, wholesaling, retailing herbal ingredients, or providing herbal ingredient preservation services must obtain a Certificate of Eligibility for Drug Business that covers herbal ingredient trading.

- Conditions for issuance of the Certificate of Eligibility for Drug Business that covers herbal ingredient trading:

+ The technical manager of the facility has a pharmaceutical practice certificate as prescribed in Article 15 of Decree No. 79/2006/ND-CP of Vietnam’s Government, except for the cases specified in Article 11 of this Circular. If a business location of a facility has various forms of drug business, only one of the technical managers has to satisfy the condition specified herein.

+ The facility satisfies conditions corresponding to its form of business as prescribed in Article 5 through 8 of this Circular.

Moreover, according to Article 6 of the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, conditions applied to facilities herbal ingredient wholesalers are specified as follows:

- GSP applied to herbal ingredients specified in Article 9 and Good Distribution Practice applied to herbal ingredients specified in Article 10 of this Circular are implemented.

- Every facility granted the Certificate of Eligibility for Drug Business that covers herbal ingredient wholesaling may also provide herbal ingredient preservation services without having to follow procedures for expansion of operating scope.

View more details at the Circular No. 03/2016/TT-BYT of the Ministry of Health of Vietnam, issued on January 21, 2016.

Le Vy

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